Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation
Brief summary
The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct open concomitant and/or hybrid ablation, and management of the LAA concomitant to a cardiac ablation.
Detailed description
Up to 10,000 patients at up to 250 sites. Participating regions may include US, Canada, Europe, Asia Pacific and others to be determined. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias. Each patient will be followed for a period of up to ten (10) years after their procedure according to the standard practice at the enrolling center. There will be no additional visits, nor procedures, for subjects who participate in the registry.
Interventions
DEVICEOpen Concomitant Surgical Ablation Procedures
AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.
DEVICEHybrid (Convergent) Ablation Procedures
AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation.
DEVICEAtriCure Hybrid Totally Thoracoscopic Ablation Procedures
AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation.
DEVICEAtriCure LAA Exclusion Procedures
AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.
Sponsors
AtriCure, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s) 2. Patient is willing to provide informed consent 3. Patient whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
1\. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's AF burden 6-month after receiving the ablation procedure | 6 months | Collect patient data on Atrial Fibrillation burden after the ablation procedure as documented by long term event monitoring or identified during the exam after a six-month recovery period. |
| Adverse events of the ablation procedure as atrial fibrillation management | 1 year | Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure. |
Countries
Austria, Canada, United States
Contacts
CONTACTJarrod Goodarz, BA
CONTACTJoey Stimler, DPT
Outcome results
None listed